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Comparison of efficacy and safety between Venetoclax, azacitidine (VA) and VA combined with low-dose cytarabine (VAA) in treatment-naive, elderly patients with acute myeloid leukemia: a randomized controlled trial

Comparison of efficacy and safety between Venetoclax, azacitidine (VA) and VA combined with low-dose cytarabine (VAA) in treatment-naive, elderly patients with acute myeloid leukemia: a randomized controlled trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088169
Enrollment
Unknown
Registered
2024-08-13
Start date
2023-11-01
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute meyloid leukemia

Interventions

Sponsors

Second Affiliated Hospital, Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The patient fully understands this study and voluntarily participates and signs an Informed Consent Form (ICF); 2. Patients diagnosed with adult acute myeloid leukemia; Elderly patients aged 60 to 90 years (including threshold); No gender limitation; 3. ECOG score = 3 points; or KPS score =90 points; or PS score =1 points; 4. The expected survival period is>3 months; 5.No radiotherapy, chemotherapy, targeted therapy, hematopoietic stem cell transplantation, or any other treatment should be received within 4 weeks prior to enrollment.

Exclusion criteria

Exclusion criteria: 1. Under 60 years old who can accept standard dose or intensive chemotherapy; 2. Individuals with severe heart disease or abnormal lung function that affects survival; 3. Merge active second tumor; 4. Can not come back for eximination on time; 5. Unsuitable subjects for this study determined by the investigator.

Design outcomes

Primary

MeasureTime frame
Rate of MRD negativity;complete remission(CR);

Secondary

MeasureTime frame
Objective Response Rate (ORR);1 years overall survival;1 year Progression-Free-Survival(PFS);Recurrence rate;Severe adverse reaction;mortality rate;

Countries

China

Contacts

Public ContactWen Qin

Second Affiliated Hospital, Army Medical University

qiqi105@sina.com+86 136 5833 7056

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026